A Medical Device Daily

Boston Scientific (Natick, Massachusetts) said Friday that it had received FDA approval to market its second-generation Taxus Liberté paclitaxel-eluting coronary stent system in the U.S.

The company said it plans to launch the stent early next month, following completion of the introduction of its Taxus Express2 Atom paclitaxel-eluting coronary stent, which received FDA approval last month.

"The Taxus Liberté stent represents our latest advance in drug-eluting stent technology," said Donald Baim, MD, chief medical and scientific officer for Boston Sci. "This device has substantially thinner struts and a more flexible cell geometry for improved deliverability, as well as uniform strut distribution designed specifically for drug elution."

He said the Taxus Liberté stent "demonstrated similar late loss and target vessel revascularization as the Taxus Express2 stent system in the ATLAS Workhorse clinical trial, despite treating more challenging patients."

Boston Scientific said the Taxus stent systems "have been evaluated by the industry's most extensive randomized, controlled clinical trial program, with follow-up to five years in some cases. These trial results have been supplemented by data on more than 35,000 patients enrolled in post-approval registries."

Wachovia Capitol Markets med-tech analyst Larry Biegelsen said he viewed the approval "as having psychological importance, but limited in terms of commercial impact." He estimated the company spent over $200 million over the last two years to resolve the problems cited in a key DA warning letter. "